Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee (the KORAL study)

Surgeons have used arthroscopic lavage and debridement for osteoarthritis of the knee for many years. The research evidence to support its claimed benefits to patients is, however, weak. A recent study, conducted in the US, suggested that the procedure was no better than sham surgery. This study aims to formally evaluate the role of arthroscopic lavage (with debridement if indicated) for osteoarthritis patients who might currently be considered for lavage. Around 530 patients who agree to join the study will be randomly allocated to one of three trial arms: arthroscopic lavage (with debridement if necessary), sham procedure or non-operative management. The effectiveness of the procedure will be measured primarily in terms of knee pain, knee-specific health status, general quality of life and cost at 24 months after surgery. Given possible concerns about the use of a sham procedure, this study will initially involve a feasibility phase to ascertain the acceptability of using a sham procedure to key stakeholder groups including surgeons, anaesthetists, people with osteoarthritis of the knee and members of research ethics committees. Progress to the full randomised controlled trial will be dependent on the findings of the feasibility phase.